Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

Phase 2

Completed

• Conditions: Plaque Psoriasis; Psoriasis
• Interventions: Drug: ARQ-151 cream 0.3%

• Registration Number: NCT04746911
• Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary

This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-03-01
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-03
• Disposition First Submitted: 2023-03-07
• Last Update Submitted: 2023-03-07
• Disposition First Posted: 2023-03-10
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Informed consent of parent(s) or legal guardian.
• Males or females, 2 to 5 years old (inclusive).
• Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
• Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
• An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
• Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands).
• In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs and hematology values.
• Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.

Exclusion Criteria

• Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
• Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
• Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
• Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period.
• Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
• Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol.
• Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ-151 cream 0.3%	ARQ-151 cream 0.3%	Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of application site reactions	Week 4	Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed
Plasma pharmacokinetic (PK) profile of ARQ-151 cream 0.3% and its major N-oxide metabolite	Week 4	Plasma levels of circulating roflumilast and its major N-oxide metabolite
Incidence of adverse events	Week 4	Number of participants with adverse events during treatment will be assessed

Trial Locations

Locations (18)

Arcutis Clinical Site 608; 🇺🇸 Los Angeles, California, United States

Arcutis Clinical Site 621; 🇨🇦 Toronto, Ontario, Canada

Arcutis Clinical Site 610; 🇺🇸 Boca Raton, Florida, United States

Arcutis Clinical Site 602; 🇺🇸 Coral Gables, Florida, United States

Arcutis Clinical Site 613; 🇺🇸 Delray Beach, Florida, United States

Arcutis Clinical Study Site 628; 🇺🇸 Miami, Florida, United States

Arcutis Clinical Site 630; 🇩🇴 Santo Domingo, Dominican Republic

Arcutis Clinical Site 606; 🇺🇸 Arlington, Texas, United States

Arcutis Clinical Site 619; 🇺🇸 Frisco, Texas, United States

Arcutis Clinical Study Site 619; 🇺🇸 Frisco, Texas, United States

Arcutis Clinical Site 609; 🇺🇸 Fountain Valley, California, United States

Arcutis Clinical Site 618; 🇺🇸 Los Angeles, California, United States

Arcutis Clinical Site 604; 🇺🇸 Scottsdale, Arizona, United States

Arcutis Clinical Site 603; 🇺🇸 Mountain Brook, Alabama, United States

Arcutis Clinical Site 611; 🇺🇸 Rancho Santa Margarita, California, United States

Arcutis Clinical Site 607; 🇺🇸 Miami, Florida, United States

Arcutis Clinical Site 605; 🇺🇸 Houston, Texas, United States

Arcutis Clinical Site 627; 🇺🇸 West Lafayette, Indiana, United States